The REGROW Act would drastically weaken FDA regulation of experimental stem cell therapies. I’ve criticized it in numerous posts (see those here) for its radical ideas that would put patients and the stem cell field at risk.

I’m not the only one concerned about it as both ARM and ISSCR oppose it too. Now 10 top patient advocacy groups together announced their opposition to it as well. The patient groups that include the Michael J. Fox Foundation (see complete list at the bottom of this email) cited their concerns over risks to patients from the bill in a letter to Senator Mark Kirk, who is the main sponsor.

I commend these patient groups for this move and I wholly agree with their sentiment that existing FDA mechanism are a better way to proceed. For instance, instead of REGROW we should be pressuring the FDA to use its Breakthrough designation and Fast Track review for stem cells more readily.

Are you aware of any mechanism for other groups to join in signing this? Our patient group is at the mercy of stem cell scammers who make bold and unrealistic promises about the potential for stem cell therapies for a genetic lung disease (similar to cystic fibrosis). In two cases, after paying huge amounts for the therapy (which did little or nothing) these patients were rendered ineligible for lung transplant due to having received commercial stem cell therapy. We are very concerned about any legislation that, even indirectly, provides cover for these operations and would love to support this effort.

Also includes The University of California-Davis Institute for Regenerative Cures
which has treated 1,000 patients in MSC trials.

Is this about safety for patients, or financial safety for the academic and commercial researchers who truly fall in the cells=drugs category?

The folks developing embryonic and iPSC therapy solutions don’t want to be stuck in the traditional FDA 10 year / $1 billion drug approval process, while REGROW cuts this in half for the adult stem cell therapies that are already making it to phase 2 trials, and would then be eligible for “conditional approval”.

One could argue that the legislators don’t grasp the nuances of the science and safety issues involved, but consider that former Senator Bill Frist, is also an MD. He expressed his support May 12th in The Wall Street Journal for Senate Cures—which includes the REGROW legislation.

@mickeymusing The REGROW legislation does not make it easier for commercial stem cell operations. The cell therapies must have made it through phase 1 and 2 clinical trials and show safety as well as signs of efficacy. Then the therapy can begin a 5 year “conditional approval” period to confirm efficacy, before final approval. Check the facts at http://www.celltherapynow.org/

Paul, finally there is something in your post that we can agree upon. You state “…we should be pressuring the FDA to use its Breakthrough designation and Fast Track review for stem cells more readily.” As you know, that idea is being discussed in many circles. Patients want safe cell therapy. We need alternatives. You state the Regrow Act would “gut stem cell oversight.” Seriously, you really believe that? Consider this. If we can’t come up with an accelerated pathway for cell therapy, stem cell products won’t reach patients for more than a decade. Add in the cost factor of $1 billion…basically, NEVER. The best option to address the issue is legislation. Ignoring the roadblock means a lifetime of suffering for some patients. Regrow is a timely demand for action.

@Bernie,
Thanks for the comment. The conditional approval system in REGROW and other elements such as no Phase III requirement are extremely risky and would strongly impair the FDA’s ability to oversee the experimental therapies.
Many folks are making the flawed assumption that if we can just get tons of still experimental therapies to patients at warp speed then everything will be peaches and cream, but in reality if said therapies don’t have enough data supporting them then all you are achieving is putting patients at greater risk & more quickly.
Paul

@SammyJoWilkinson
Thanks for the link, but please don’t assume anyone who doesn’t agree with your position is unaware of the facts or that they will be swayed by testimonial over evidence. Skipping over the need for phase III trials would indeed provide cover for some of these commercial operators who are providing unproven therapies. It is relatively cheap and easy to accomplish the limited goals of phase I and phase II trials. Many therapies that pass phase I and phase II fail to meet their endpoints in phase III. No doubt the people lobbying for this legislation are well aware of this and just believe the rest of us are too ignorant to understand their clever plan. In practice, this would give these clinics the ability to claim ‘FDA approval’ without having to actually prove much at all and we would move right into phase IV, post-marketing with patients as Guinea pigs to see what the therapy actually does in large scale use.

I’ll stick with quality over quantity when it comes to patient group endorsements. You simply can’t overstate the credibility of the groups who are signatories to this letter.

It seems the debate over US cell therapeutic legislation in the blog sphere misses a fundamental issue in question here > How to enact law that meets the requirements of curtailing dangerous rogue stem cell practices that pray on the most vulnerable, by bringing those solutions within the existing structure of the FDA, while allowing for patient access and sector growth. Leaving the system as it is leaves the door too wide open while requiring complete adherence to rules written for completely different forms of medicine. Without new pathways we limit the field and it’s potential for meaningful numbers of clinical trial patient data which is required for the sector to gain traction. Being a researcher funded by grants with a view to wanting to be absolutely sure of the MOA is fine if we had the continuing luxury of hundreds of billions and decades more considering the spend to-date if you look hard at the numbers, reproducible factor and real world outcomes. However IMO we don’t and shouldn’t consider this question solely about what is best for the science but also factor in the burden health is playing on society and the patients themselves. Cheers